The road to affixing a CE mark can be confusing. An often-asked question is ‘What is the CE marking process?’ In this article we try to shed some light on the different steps you have to take to comply with the EU directives and be able to place those two letters on your product.
The very first step of the CE marking process is to verify whether your product should be marked or not. In short, you have to check whether your product requires any CE marking at all.
To do so, you can check what the CE marking requirements are. Amongst the products that require CE marking are machinery, toys, medical devices, lifts, wireless devices, construction products and electrical equipment.
This step of the CE marking process is a vital first step. It may be the case that your specific product does not require any CE marking.
The second step of the process is to research whether your product meets the requirements of the EU directives. This may involve the design or the manufacturing of your product.
There are different requirements for different products. Each directive states essential requirements per product category. In order to comply with these requirements, you have to meet so called harmonized European Norms; hENs for short.
Once you’ve taken step 2 in the CE marking process, it is time to determine what the route is to conformity. This step may require the help of a third party.
As a part of this process it is important to check whether your product needs to be tested by an assessment body, also called a Notified Body. This body will verify that your product meets the requirements laid out in the directives of the EU.
Making use of a Notified Body is not mandatory for all products. Therefore, first establish whether your product will require the help of a Notified Body. The European Commission has compiled a list of Notified Bodies.
If your product does not require a Notified Body, the next step is to test the product yourself. In this part of CE marking process you assemble proof that your product actually complies with the EU’s requirements.
As a part of this step, estimate and document possible risks that customers might have when using your products. The testing is often done to comply with the harmonized European Norms that were mentioned in step 2.
Once you have completed the proper testing, you have to compile the information. This step means you collect details on your conformity to the EU directives. Details may include information on the manufacture, design and development of your product. This file is often known as the technical file. Amongst the documents to collect are:
The file can contain more information than what is listed above. Just keep in mind what information is required to show you comply with the EU directives. The technical file does not have to be published or given to your customers. It is simply there to show once an authoritative figure who has the power to enforce the directives asks for it.
Once you’ve established you meet the EU’s requirements, it is time to complete a declaration. This declaration is often called the Declaration of Conformity. This declaration simply states that your product meets the legal requirements set by the European Union. The declaration will also be a part of your technical file (see step 5 of the CE marking process).
After this, you can affix the CE mark to your product. This means you can enjoy the benefits of this mark for trading within Europe and showing your customers your product is safe to use.